Choosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy

Status: Completed
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this study is to determine which of two treatments (acupuncture or cognitive behavioral therapy) works better for treating insomnia in cancer survivors. The investigator also wants to study the factors that might impact why someone might prefer or do better in one treatment over the other. Group 1 will get Acupuncture - Acupuncture is an ancient Chinese Technique of using very thin needles inserted in the skin to treat different symptoms and illness, and to promote healing. Group 2 will get Cognitive Behavioral Therapy for Insomnia (CBT-I) - CBT-I is a treatment to address behaviors and thoughts that are known to effect problems with sleep.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• English-speaking, age ≥ 18 years old

• A diagnosis of cancer with no restrictions placed on type of cancer or stage. Eligibility criteria are not be restricted to MSK confirmed biopsy/diagnosis. Participating institution's testing is sufficient for other study sites.

• Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least one month prior to study initiation (patients on continued hormone treatment or maintenance targeted therapies will not be excluded).

• A score >7 on our primary outcome (the Insomnia Severity Index)

• A diagnosis of insomnia disorder as defined by the Diagnostic and Statistical Manual of Mental disorders, 5th Edition (DSM-5), per the diagnostic interview. According to this nosology, insomnia is defined as dissatisfaction with sleep quality or quantity characterized by difficulty initiating sleep, maintaining sleep, or early morning awakenings that cause significant distress or impairment in daytime functioning and occur at least three nights per week for at least three months despite adequate opportunity for sleep.

• Patients using psychotropic medication (e.g. antidepressants) will remain eligible for study participation provided that the dose was not recently altered (stable over the previous 6-weeks).

• Patients using hypnotics or sedatives will be eligible for study participation. Considering the high use of benzodiazepines within the oncology population, past research has included participants who met diagnostic criteria for insomnia, despite the use of benzodiazepines, and included monitoring of medication use.

Locations
United States
New York
Memorial Sloan Kettering Cancer Center
New York
Pennsylvania
Abramson Cancer Center of The University of Pennsylvania
Philadelphia
Time Frame
Start Date: February 2015
Completion Date: July 2017
Participants
Target number of participants: 160
Treatments
Active Comparator: Acupuncture Group
In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks.
Active Comparator: CBT-I Group
In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks.
Authors
Jun Mao, Philip Gerhman
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center
Collaborators: University of Pennsylvania

This content was sourced from clinicaltrials.gov

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